Senior Manager, Clinical Regulatory Affairs (Biotech)

Location: Remote in the United States; candidates based in Seattle, Washington must work onsite at the Seattle office 2 days per week. Travel may be required.

Salary: Senior Manager $159,800–$197,400 annually; Associate Director $164,500–$202,650 annually.

Company

hirify.global is a biotechnology company developing off-the-shelf immunotherapies, including in vivo CAR T and cell and gene therapy programs for cancer treatment.

What you will do

• Support global clinical regulatory strategies for early- and mid-stage development programs.
• Prepare, review, and maintain INDs, CTAs, protocol amendments, annual reports, briefing packages, health authority responses, and marketing application components.
• Plan and support FDA, EMA, national competent authority, and other global health authority meetings.
• Provide regulatory input into clinical study designs, protocols, investigator brochures, informed consent documents, and safety reports.
• Partner with clinical, medical writing, pharmacovigilance, CMC, nonclinical, program management, and external regulatory teams.
• Identify regulatory risks, maintain submission plans and trackers, and improve processes, templates, and inspection-readiness practices.

Requirements

• Required: Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related field; an advanced degree is preferred.
• Senior Manager candidates need 5+ years of relevant regulatory affairs experience; Associate Director candidates need 8+ years supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs.
• Hands-on experience with FDA submissions and interactions, including INDs, protocol amendments, annual reports, safety reports, briefing packages, and information-request responses.
• Experience with EU or global clinical trial applications, CTAs, substantial amendments, and EMA or national competent authority interactions.
• Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements, GCP, and global clinical development expectations.
• Strong communication, project management, organizational, regulatory judgment, and cross-functional collaboration skills.

Nice to have

• Experience in biotechnology, pharmaceutical, or cell and gene therapy environments.
• Experience with oncology, immunotherapy, biologics, or rare and serious disease development.

Culture & Benefits

• Work in a growing biotechnology organization focused on novel cancer therapies and patient-focused drug development.
• Medical, dental, and vision plans.
• 401(k) plan with a 100% match on the first 4% of employee deferrals.
• Paid time off, commuter benefits, and a cell phone stipend.
• Evening, holiday, and weekend work may be required when needed.